Potency testing

The quality control of immunoglobuhns includes potency tests and conventional tests of safety and sterihty. The potency tests consist of neutrahzation tests that parallel those used for the potency assay of immunosera, except that in the cases of some immimoglobulins the assays are made in vitro, fit addition to the safety and sterihty tests, total protein is determined by nitrogen estimations, the protein composition by... 

Skin sensitization ELISA test for batch potency testing of erysipelas vaccines EU... 

All pharmaceutical finished products undergo rigorous QC testing in order to confirm their conformance to predetermined specifications. Potency testing is of obvious importance, ensuring that the drug will be efficacious when administered to the patient. A prominent aspect of safety testing entails analysis of product for the presence of various potential contaminants. 

Time. Most bioassays take days, and in some cases week, to run. This can render routine bioassays difficult, and impractical to undertake as a quick QC potency test during downstream processing. 

Changes of cellular immune response can be quantified, enabling potency testing. 

The strength of certain viral vaccines is expressed as international units (IU), which are based on animal potency tests (e.g., rabies vaccine). 

The same process that will be used for commercial-scale production should be adopted to produce the material used in the preclinical and clinical trials. Significant differences in the production process used to obtain this material can invalidate the clinical trial results for the commercial product, unless the comparability is demonstrated by identity, purity, stability, and potency tests (ICH, 1998b). 

Virulence and Potency Testing Live attenuated viral vaccines are considered to have a theoretical risk of reversion to virulence that needs to be tested. This is done by monitoring genetic or phenotypic markers of attenuation or virulence and can include in vitro and in vivo potency tests [62],... 

The authors performed RAST inhibition to measure the relative potencies of the different venom extracts using the patient s serum as a source of IgE anti-venom. Although they initially suspected the new source of Polistes wasp venom, the relative potency tests showed greater variation in the honeybee venom. The IgG concentrations were consistent with this finding. This report emphasizes the care that must be taken with the preparation of each injection, especially when using a new batch of antigen. 

The quality of immune sera is controlled by potency tests and by conventional tests for safety and steril-... 

In vitro assays do not use any whole-cell or animal-based components. The fibrin clot lysis assay, as established for tissue plasminogen activators and described for alteplase in the USP, is an example of this type of potency testing [5]. By means of defined standard materials, a fibrin clot is formed and the time to complete lysis is characterized as measure of potency, compared to a reference standard with defined activity. The LAL-test is a well-established and internationally harmonized in vitro alternative to detect or quantify bacterial endotoxins, using Limulus amebocyte lysate (LAL) obtained from the aqueous extracts of circulating amebocytes of horseshoe crab (Limulus polyphemus or Tachypleus tri-dentatus) which has been prepared and characterized appropriately [5]. Two types of technique may be used for this test gel-clot techniques, which are based on gel formation and photometric techniques. 

The results from Compound I led to the conclusion that since the R S potency ratio was the same in vitro and in vivo and in both central and peripheral potency tests, the anticholinergic receptor must be the same in the guinea pig ileum, the mouse eye, the mouse salivary gland and in the CNS. With regard to studies of behavioural effects, the implication of this conclusion is that if the behavioural effects of anticholinergic drugs are directly related to their anticholinergic properties then the ratio... 

Where applicable, a description of the potency test or tests for measuring biological activity, including specifications for potency determination... 

She continues to think about the literature search, which may answer another question what structural analogs of Phrmco 133997 have other chemists already made and published Such substances may be items of commerce. If any are, then the chemist would be wise to buy and submit them for testing in the primary assay. Knowledge of their structure-activity relation directs a quest for novel compounds with high potency. Testing commercially available, structurally known substances can quickly and inexpensively illuminate this relation. 

Bioassay Based on biological effects of proteins (e.g., cell proliferation, cytotoxicity, and antiviral activity.) Quantitative analysis potency test [230-231]... 

Product Potency Tests. Two assays were developed that measure the potency of the FGF-4 protein. In the first case, a one-step growth promotion assay is conducted on normal, human retinal pigment epithelial cells (ARPE-19). The assay measures metabolic activity (Alamar blue dye metabolism) after infection of ARPE-19 cells with a serial dilution of the drug substance (Ad5FGF-4). The increase in metabolic activity correlated with FGF-4 protein production (determined by an FGF-4 ELISA), increased de novo DNA synthesis (measured by BrdU incorporation), and an increase in cell number. 

Potency tests for the polysaccharide vaccines and the acellular pertussis component of the DTaP Vaccine tolerated the irradiation doses. Molecular sizing experiments indicated some size change for the polysaccharides studied. Further studies are required to determine the specific doses at which sterility is achieved, as well as to determine that the therapeutic effect of the... 

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